SINOLPAN

SINOLPAN forte 200 mg gastro-resistant soft capsules

Important notes (mandatory information)

Sinolpan forte 200 mg enteric-coated soft capsules. Active ingredient: Cineole. Areas of application: for the treatment of symptoms in bronchitis and colds of the respiratory tract, for additional treatment in chronic and inflammatory diseases of the respiratory tract, e.g. of the paranasal sinuses (sinusitis).

For risks and side effects, read the package leaflet and ask your doctor or pharmacist!


PACKAGE LEAFLET: INFORMATION FOR THE USER

Sinolpan forte 200 mg enteric-coated soft capsules for adults and adolescents aged 12 and over
Active ingredient: Cineole

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or even worse after 7 days, contact your doctor.

What this package leaflet contains

1. WHAT IS SINOLPAN FORTE AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING SINOLPAN FORTE?
3. HOW TO TAKE SINOLPAN FORTE?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE SINOLPAN FORTE?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS SINOLPAN FORTE AND WHAT IS IT USED FOR?

Sinolpan forte contains the active ingredient cineole. Sinolpan forte is an anti-inflammatory and expectorant medicine for additional treatment in diseases of the respiratory tract. For the treatment of symptoms in bronchitis and colds of the respiratory tract. For additional treatment in chronic and inflammatory diseases of the respiratory tract, e.g. of the paranasal sinuses (sinusitis). The medicine is intended for use in adolescents (12-17 years) and adults.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING SINOLPAN FORTE?

Sinolpan forte must not be taken:

• if you are allergic to cineole or any of the other ingredients of this medicine listed in section 6.
• in whooping cough and croup.
• in children under 12 years of age.

Sinolpan forte contains phospholipids from soybeans. It must not be taken if you are hypersensitive (allergic) to peanuts or soy.

Warnings and precautions

Please talk to your doctor or pharmacist before taking Sinolpan forte. Special care should be taken when taking:

• Diseases associated with pronounced hypersensitivity of the respiratory tract.
• In bronchial asthma and COPD, Sinolpan forte should only be taken under medical supervision, as an individual benefit/risk assessment is required.
• If symptoms persist for more than a week, if you have shortness of breath, fever or purulent or bloody sputum, you should see a doctor.

Taking Sinolpan forte with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines. Cineole induces the induction of metabolising enzymes in the liver in animal experiments. It is therefore not impossible that high doses of cineole will weaken and/or shorten the effect of other medicines. However, such an effect has not yet been observed in humans when cineole is used as intended.

Pregnancy and

breastfeeding

If you are pregnant or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

There are no scientific studies on the use of Sinolpan forte in pregnant women. If you are pregnant, you should only use Sinolpan forte after consulting your doctor. In animal experiments on rats, cineole, the active ingredient of Sinolpan forte, passes through the placenta and reaches the foetus, but the animal experimental data available to date do not provide any evidence of malformations.

Breastfeeding

Due to the fat-soluble properties of the active ingredient, it cannot be ruled out that it will pass into breast milk. However, there are no systematic studies on this, particularly with regard to the possible occurrence of undesirable medicinal effects. Essential oils can change the taste of milk and lead to drinking problems. Sinolpan forte should only be used during breastfeeding after consulting your doctor.

Driving and operating machinery

Sinolpan forte has no or negligible influence on the ability to drive and operate machinery.

Sinolpan forte contains sorbitol

Sinolpan forte contains 16.88 mg sorbitol per capsule.

3. HOW TO TAKE SINOLPAN FORTE?

Always take this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the recommended dose is

Age Single dose Total daily dose
Adults and adolescents aged 12 and over 1 capsule (equivalent to 200 mg cineole) 2 - 4 capsules (equivalent to 400 - 800 mg cineole)

The medicine is intended for use in adolescents (12-17 years) and adults. Adults and adolescents aged 12 and over take 1 capsule 3 times a day. In particularly persistent cases, 1 capsule 4 times a day. For further and long-term treatment, 1 capsule 2 times a day is generally sufficient.

Method of administration

The medicine is intended for oral use. Please take Sinolpan forte unchewed with plenty of not too hot liquid (preferably a glass of drinking water [200 ml]) if possible half an hour before a meal. If you have a sensitive stomach, it is advisable to take Sinolpan forte during meals. The duration of use depends on the type, severity and course of the disease. If symptoms persist for more than a week, if you have shortness of breath, fever or purulent or bloody sputum, you should see a doctor.

Please talk to your doctor or pharmacist if you have the impression that the effect of Sinolpan forte is too strong or too weak.

If you have taken more Sinolpan forte than you should

Poisoning with Sinolpan forte has not been reported to date. If you suspect an overdose of Sinolpan forte, please inform your doctor. Depending on the severity of the poisoning symptoms, he/she can decide on the measures to be taken, if necessary. Possible symptoms of an overdose of Sinolpan forte include central nervous disorders such as clouding of consciousness, fatigue, weakness of the extremities, excessive constriction of the pupils (miosis) and, in severe cases, coma and respiratory disorders.

If you forget to take Sinolpan forte

Do not take twice the amount if you have forgotten to take the previous dose.

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. Information on the frequency of side effects is based on the following categories:

• Gastrointestinal complaints (nausea, diarrhoea) may occur occasionally (may affect up to 1 in 100 people).
• Hypersensitivity reactions (facial oedema, itching, shortness of breath, coughing) and difficulty swallowing are rare (may affect up to 1 in 1,000 people).

At the first signs of a hypersensitivity reaction, Sinolpan forte must not be taken again.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de by reporting side effects, you can help to provide more information on the safety of this medicine.

5. HOW TO STORE SINOLPAN FORTE?

Keep medicines out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister pack after "Use by". The expiry date refers to the last day of the month indicated. Store in the original package to protect the contents from moisture. Do not store above 30°C. Do not dispose of medicines in wastewater. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Sinolpan forte contains

The active ingredient is: Cineole. 1 enteric-coated soft capsule contains 200 mg cineole. The other ingredients are: Capsule contents: Medium-chain triglycerides Capsule shell: Gelatin, methacrylic acid-ethyl acrylate copolymer-(1:1)-dispersion 30% (Ph.Eur.), sorbitol solution 70% (non-crystallising) (Ph.Eur.) (E 420), phospholipids from soybeans (E322), glycerol 85%, propylene glycol, glycerol monostearate 40-55, polysorbate 80 [vegetable], sodium dodecyl sulphate.

What Sinolpan forte looks like and contents of the pack

Sinolpan forte are oval and colourless capsules. Packs of 21 (N1), 50 (N2), 100 (N3) enteric-coated soft capsules. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur and manufacturer

Engelhard Arzneimittel GmbH & Co. KG
Herzbergstraße 3
61138 Niederdorfelden
Telephone: 06101/539 - 300
Telefax: 06101/539 - 315
Internet: www.engelhard.de
E-mail: info@engelhard.de Arzneimittel

This package leaflet was last revised in February 2018.

Source: Information from the package leaflet
Status: 10/2019
Active ingredient: Cineole. Areas of application: for the treatment of symptoms in bronchitis and colds of the respiratory tract, for additional treatment in chronic and inflammatory diseases of the respiratory tract, e.g. of the paranasal sinuses (sinusitis).